Completed

A Phase I Trial Of A COX-2 Inhibitor (Celecoxib) In Combination With An EGFR Inhibitor (OSI-774) In Metastatic Non-Small Cell Lung Cancer

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What is being tested

Data Collection

Who is being recruted

Bronchial Neoplasms
+7

+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Over 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2003
See protocol details

Summary

Principal SponsorJonsson Comprehensive Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2003Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the biologically active dose of celecoxib administered with erlotinib in patients with stage IIIB or IV non-small cell lung cancer. * Determine the toxicity profile of this regimen in these patients. Secondary * Determine the clinical activity of this regimen, in terms of reduction in tumor burden, in these patients. * Correlate biological endpoints with cyclooxygenase-2 and epidermal growth factor receptor inhibition in patients treated with this regimen. OUTLINE: This is a nonrandomized, dose-escalation study of celecoxib. Patients receive oral erlotinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue treatment beyond 2 courses at the investigator's discretion. Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) and biologically active dose (BAD) are determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). The BAD is defined as the maximum decrease in the level of PGE_2 where no DLT occurs. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 21-27 patients will be accrued for this study.

Official TitleA Phase I Trial Of A COX-2 Inhibitor (Celecoxib) In Combination With An EGFR Inhibitor (OSI-774) In Metastatic Non-Small Cell Lung Cancer 
NCT00072072
Principal SponsorJonsson Comprehensive Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bronchial Neoplasms
Carcinoma, Bronchogenic
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIB or IV * Measurable disease * Progressive disease after at least 2 prior standard chemotherapy regimens OR refused standard chemotherapy * No active CNS metastases PATIENT CHARACTERISTICS: Age * 21 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 2.5 times upper limit of normal (ULN) * PT and/or PTT no greater than 1.5 times ULN Renal * Creatinine no greater than 2 mg/dL Cardiovascular * No New York Heart Association class III or IV cardiac disease * No myocardial infarction within the past year * No symptomatic ventricular arrhythmia * No symptomatic conduction abnormality Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior gastrointestinal ulceration, bleeding, or perforation * No hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or other reagents used in this study * No concurrent disease or medical condition that would preclude study treatment or compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy Endocrine therapy * More than 4 weeks since prior corticosteroids * No concurrent steroids (including chronic use) * Concurrent topical steroids allowed Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Not specified Other * More than 4 weeks since prior non-cytotoxic investigational agents * More than 3 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs) * No prior cyclooxygenase-2 (COX-2) inhibitors for metastatic NSCLC * No prior epidermal growth factor receptor inhibitor for metastatic NSCLC * No concurrent COX-2 inhibitors * No concurrent NSAIDs * No concurrent fluconazole or lithium

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Jonsson Comprehensive Cancer Center at UCLALos Angeles, United StatesSee the location
CompletedOne Study Center